ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE


Device Classification Name

wire, guide, catheter

510(k) Number K110553
Device Name ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
Applicant
ASAHI INTECC USA, INC.
2500 red hill avenue
suite 210
santa ana, 
CA 
92705

Applicant Contact yoshi terai
Correspondent
ASAHI INTECC USA, INC.
2500 red hill avenue
suite 210
santa ana, 
CA 
92705

Correspodent Contact yoshi terai
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 02/28/2011
Decision Date 03/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No